Study Delivery Lead - based in Europe
- Experience Level
Providing innovative solutions for our clients is what we do. But innovation just for the sake of innovation isn’t why we do it. Side-by-side with our clients, we strive to move drug discovery forward, to help them develop life-saving and life-improving drugs. We help change people’s lives for the better every single day. It’s who we are. And it’s who you could be too.
Working fully embedded within one of our pharmaceutical clients, with the support of PRA right behind you, you’ll be at the heart of our client’s innovation.
As a Clinical Delivery Lead you will be dedicated to one of our global Pharmaceutical clients. As one of the world’s leading and most trusted healthcare companies they place their core values and commitment to scientific innovation are at the heart of everything they do.
Key responsibilities will include:
- In partnership with the lead physician, Clinical Scientist and all study team members, accountable for the co-ordination of full feasible study protocol development
- Oversight of delivery quality for in house and outsourced studies
- Lead escalation and resolution of any issues with CRO/ vendors/ site/ country performance raised by the study team, including serious quality incidents and serious breaches of GCP
- Maintain regular interaction with all study team members to ensure issues / risks / successes with study delivery are reviewed and/or shared as they occur
- In outsourced studies lead key discussions with CRO suppliers to ensure appropriate expectations have been set and are aligned on delivery strategy and provide holistic oversight of CRO – understand study contribution to program/submission
- Delivery of study plan by implementing innovative approaches
- Accountability for study delivery strategy (e.g. country selection, diversity, patient engagement strategy etc) in collaboration with other stakeholders
- Act as a single point accountability for the operational delivery of clinical study to time, quality and budget (through to completion of TMF archiving)
- Drive assessment, selection, engagement and management of appropriate vendors for outsourced clinical activities/services; ensures adherence to Oversight Plans and Outsourcing Handbooks as appropriate
- Ensure inspection readiness for study at all times and overall accountability for eTMF
- Ensure development, review, finalization and delivery of high-quality key clinical study documents in order to meet study timelines
- Ensure timely, accurate reporting and disclosure of study results and archiving of study records
- Ensure that a study level operational risk management plan is in-place and applies a smart-risk taking philosophy
- Provide leadership at study level to ensure accuracy, quality and timeliness of update of operational data maintained in systems used to track studies
An innovator, motivator and delivery-focused.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- An ability to combine creativity, leadership and experience to empower a team to succeed
- Solid experience of study management and project management at CRO or pharma company
- Confidence in your decision-making abilities
- Ability to lead cross-functional team and set priorities and performance targets in a global environment
- Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment
- Effective problem solving and conflict resolution skills with a solutions-oriented mindset
- Appropriate project management skills
- Strong communication skills appropriate to the target audience, promoting effective decision-making where necessary
- Ability to challenge current process to drive towards efficient ways of working to enable CRO to take accountability for quality delivery
- A BA or BS degree in a health or science related discipline
- Fluency in English and local language
- Experience in the area of vaccines highly recommendable
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.
For more information please visit our website: www.prahs.com